Medical Systems Business Area enhancing its manufacturing quality systems following U.S. FDA inspections
The Medical Systems Business Area of Getinge Group announced today that, over the past year, a number of its manufacturing facilities have been inspected by the U.S. Food and Drug Administration (FDA). As a result of the inspections, as well as its own internal quality evaluations, Medical Systems is in the process of making significant improvements to enhance the quality management systems at its manufacturing facilities around the world.
The FDA inspections generated observations related to the Business Area’s quality management systems and these observations are being used to help guide the improvements now underway. Medical Systems is in discussions with the FDA about these inspectional observations and is committed to promptly addressing them.
With these improvements, all Medical Systems facilities will have in place state of the art manufacturing quality systems, and the Business Area will be well positioned in the future to continue to provide medical products of the highest quality.
For further information, please contact:
CEO, Getinge Group
Tel: +46 10 335 00 00
GETINGE GROUP is a leading global medical technology company with operations in the areas of surgery, intensive care, infection control, care ergonomics and wound care. The Group is organized into three business areas: Extended Care, Infection Control and Medical Systems, and operates under the ArjoHuntleigh, GETINGE and MAQUET brands.